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NCT00171132 Clinical Trial

VALENCE: Valsartan Versus Atenolol on Exercise Capacity in Hypertensive Overweight Postmenopausal Women

Hypertension Clinical Trial

Official title:
A 26-week Double-blind, Randomized, Multicenter Parallel-group Trial to Compare the Effects of Valsartan Versus Atenolol on Exercise Capacity in Hypertensive Overweight Postmenopausal Women With Impaired Exercise Tolerance

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00171132
Other study ID # CVAL489ADE21
Secondary ID
Status Completed
Phase Phase 4
First received September 10, 2005
Last updated February 21, 2017
Start date August 2004
Est. completion date August 2007

Study information
Verified date February 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to show that valsartan compared to atenolol has favorable effects on exercise capacity, quality of life, diastolic function and elevated blood pressure in hypertensive postmenopausal overweight women with impaired exercise tolerance despite normal left ventricular ejection fraction (LVEF).

Recruitment information / eligibility
Status Completed
Enrollment 64
Est. completion date August 2007
Est. primary completion date August 2007
Accepts healthy volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Body mass index (BMI) must be = 27 and < 35

- Symptoms of impaired exercise capacity (e.g. who report shortness of breath on exertion when questioned) reported at Visit 1 or patients who have a history of shortness of breath which improved under diuretic therapy

- LV ejection fraction must be > 45% measured by echocardiography at Visit 2.

- Impaired exercise capacity measured by VO2max at Visit 4:

VO2max >14 and < 22 ml ·kg-1 ·min-1

Exclusion Criteria:

- Mean sitting diastolic blood pressure (MSDBP) = 110 mmHg and/or Mean sitting systolic blood pressure (MSSBP) = 180 mmHg

- LVEF = 45 %

- Inability to completely discontinue all previous antihypertensive medications safely for the duration of the study

- Heavy smokers (>20 cigarettes/day)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• valsartan

• atenolol

• hydrochlorothiazide

Locations
Country Name City State
Switzerland Novartis Pharmaceuticals Basel

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Countries where clinical trial is conducted

Germany,  Switzerland, 

References & Publications (1)

Düsing R, Handrock R, Klebs S, Tousset E, Vrijens B. Impact of supportive measures on drug adherence in patients with essential hypertension treated with valsartan: the randomized, open-label, parallel group study VALIDATE. J Hypertens. 2009 Apr;27(4):894 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in exercise capacity measured by oxygen consumption during exercise testing, after 26 weeks
Secondary Change from baseline in diastolic heart function after 26 weeks, measured by echocardiography
Secondary Change from baseline in heart rate and blood pressure,
Secondary during exercise testing after 26 weeks
Secondary Change from baseline in heart size after 26 weeks, measured by echocardiography
Secondary Change from baseline in quality of life measures after 26 weeks
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